Regulatory Affairs

Featured Publication: Life Sciences Guide
Contacts
T: +66 2056 5871
T: +66 2056 5610
T: +84 4 3772 5606
T: +855 23 964 210
T: +6221 2971 8099
T: +66 2056 5871
T: +95 1 255 208

Tilleke & Gibbins paves the way for life sciences clients to enter and excel in markets throughout Southeast Asia. From research and development and clinical trials to registration and market entry to commercialization and technology transfer, we assist leading and soon-to-be-leading companies through every stage of a product’s life cycle. And when shifting government policies threaten progress, we step in, build coalitions, and facilitate positive change.

Our dynamic group is built on decades of practice in the region and is committed to keeping pace with discovery and innovation. Our client teams are led by experienced attorneys and specialized practitioners and include, as appropriate to the client and its industry, pharmacists, agricultural consultants, and other regulatory specialists. We guide our clients through the layers of formal and informal rules, policies, and procedures, and help our clients forge constructive relationships with regulatory authorities.

Tilleke & Gibbins’ Regulatory Affairs group consistently earns the trust of top companies in the pharmaceutical, cosmetics, consumer products, food and beverages, biotech, medical devices, veterinary products, and other life sciences sectors. Our practice spans the following disciplines:  

  • Clinical Trials and Consumer Testing 
  • Food and Drug Administration (FDA) Registration
  • FDA Import, Export, and Manufacturing Licenses
  • Ministry of Agriculture (MOA) Crop Care Registration
  • MOA Animal, Aquatic, and Hazardous Substance Registration
  • MOA Import, Export, and Manufacturing Licenses
  • Holding Licenses 
  • Regulatory Compliance and Maintenance 
  • Labeling and Advertising Clearance
  • Intellectual Property
Among our recent matters, we have: 
 
  • Acted as counsel to a major pharmaceutical company, which representation included liaising with the Thai FDA on marketing compliance issues, verifying that the client’s marketing activities were in compliance with the complex regulations governing pharmaceutical practice in Thailand, and preventing and mitigating risk and loss.

  • Helped a multinational food company comply with Thai FDA requirements. Advised the client on advertising and promotional materials in Thailand, with particular emphasis on the requirements of the FDA and the consequences of improper ad content.

  • Acted on behalf of a major U.S.-based agrichemical manufacturer. The case involved termination of the client’s distributor for breach of contract and IP (patent and trademark) infringement. In addition, we represented the client in re-registration of its full range of products with the Thai Ministry of Agriculture.

  • Negotiated with the Thai FDA to reclassify a client’s drug product from a new chemical entity (NCE) to new combination (NCO) and secured the successful registration of this product.

  • Answered a critical client inquiry on whether their products could be imported without a certificate of formula disclosure provided to the Customs officer.

  • Secured an export license for the client in an efficient manner, as required by the head of the product group.

  • Coordinated the actions of multiple parties (the reviewers in Thailand, the foreign regulatory affairs authority, and the firm) to timely secure a pharmaceutical product license for the client.

  • Helped an Italian pharmaceutical company prepare an application dossier and obtain a license to operate in the area of medicinal products.

  • Handled a portfolio of products of a pharmaceutical client.  Our representation included assisting in the registration of the products, reviewing and advising on product labels, and assisting in transferring the products to a third company.

  • Secured medical device registration for a top shoe manufacturer and trader in Thailand by giving beneficial advice to the client and working closely with the client to resolve issues with its application. 

  • Registered, in a seamless and efficient manner, a cosmetic product for a large importer in a limited period of time, which enabled the client to timely launch the product.

  • Advised a global pharmaceutical company on all aspects of doing business in Vietnam, including the formation and operation of a representative office, registration as a foreign pharmaceutical company, property transactions, and employment termination and labor disciplinary procedures.

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Name Positionsort icon Office

Kien Trung Trinh

T:+84 4 3772 5567

E-mail

Associate
Hanoi

Tu Ngoc Trinh

T:+84 4 3772 5556

E-mail

Associate
Hanoi

Chuyen Hong Huu Le

T:+84 8 3936 2079

E-mail

Associate
Ho Chi Minh City

Niko Myint Soe

T:+95 1 255 208

E-mail

Associate
Yangon

Pichrotanak Bunthan

T:+855 23 964 210

E-mail

Associate
Phnom Penh

Daraboth Kim

T:+855 23 964 210

E-mail

Associate
Phnom Penh

Siraprapha Rungpry

T:+66 2056 5874

E-mail

Consultant
Bangkok

Wongrat Ratanaprayul

T:+6221 2971 8099

E-mail

Consultant
Jakarta
Bangkok

Jim Dao

T:+84 8 3936 2062

E-mail

Consultant
Ho Chi Minh City

Irene Djalim

T:+6221 2971 8001

E-mail

Consultant
Jakarta
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Date Titlesort icon
May 6, 2015

Alan Adcock and Areeya Pornwiriyangkura to Present at Asian Food Franchising Forum

Alan Adcock

Alan Adcock, a partner and deputy director of the intellectual property department at Tilleke & Gibbins, and Areeya Pornwiriyangkura, an attorney-at-law in Tilleke & Gibbins’ intellectual...

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March 29, 2016

Alan Adcock Recognized in Who’s Who Legal Life Sciences 2016

Alan Adcock

Who’s Who Life Sciences 2016 has recognized Alan Adcock, partner and deputy director of Tilleke & Gibbins’ intellectual property and regulatory affairs group, as a leading life sciences expert...

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August 13, 2015

Alan Adcock to Serve as Panelist on Agribusiness and Food at ASEAN-EU Business Summit

Alan Adcock

Alan Adcock, partner and deputy director of the intellectual property department at Tilleke & Gibbins, will participate in a panel discussion on agribusiness and food at the “4th ASEAN-EU...

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June 9, 2015

ALB Diversity List 2015: Tilleke & Gibbins Counted Among Top Firms

Tiziana Sucharitkul, Darani Vachanavuttivong

Tilleke & Gibbins has been included in the first edition of the Diversity List, a list compiled by Asian Legal Business—forming part of the magazine’s “Women in Law” feature—that...

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March 16, 2015

ALB Power List 2015: Tilleke & Gibbins Ranked Among Top Law Firms in Asia

Placing our firm at the pinnacle of Asia’s legal market, Asian Legal Business  has ranked Tilleke & Gibbins among the top ten “domestic” law firms in Asia in the inaugural...

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Date Titlesort icon
January 23, 2017

2016 Pharmaceutical Patent Overview for Vietnam

Thomas J. Treutler, Thang Duc Nguyen, Hien Thi Thu Vu

With a population approaching 100 million, a burgeoning health care industry, increasing consumer affluence, and relatively weak competition from local pharmaceutical manufacturers, Vietnam would...

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June 4, 2007

A Guide to the Alcohol Ad Ban

Michael Ramirez

Recently the Thai government has expressed its intent to enforce a total ban on alcohol advertising in the Kingdom. The ban, which was originally introduced by the Thai Food and Drug...

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November 30, 2010

Advertising in the Face of Food and Drug Administration Restrictions

In making a product stand out in a highly competitive market, business owners may be tempted to neglect legal restrictions on what they can claim about their product. Such marketing-driven...

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May 1, 2009

Advertising Materials: Process and Legal Concerns

In producing advertising material, skepticism can cause complications and a great deal of expense to your company. Due diligence on intellectual property and regulatory compliance of advertising...

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October 5, 2015

Amendments to Cosmetics Act Introduce Renewal Requirements and Fees

Alan Adcock, Atthachai Homhuan

New amendments to Thailand’s Cosmetics Act aim to update the decades-old law and harmonize the country’s cosmetics control system with the systems of other ASEAN countries.

Previously, a...

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